Epicardial clip

ABSTRACT

An epicardial clip for reshaping the annulus of the mitral valve of a heart. The epicardial clip includes a curved member having an anterior segment configured to be positioned in the transverse sinus of the heart, a posterior segment configured to be positioned on the posterior side of the heart, such as on or inferior to the atrioventricular groove, and a lateral segment extending between the anterior segment and the posterior segment. The lateral segment includes a curve such that the first end of the member is positioned at or above the plane of the mitral valve and the second end of the member is positioned at or below the plane of the mitral valve.

TECHNICAL FIELD

The disclosure is directed to medical devices for reshaping the annulusof a heart valve. More particularly, the disclosure is directed to anepicardial clip which may be positioned exterior of the epicardium of aheart to reshape the annulus of the mitral valve to improve coaptationof the leaflets of the mitral valve.

BACKGROUND

The mitral valve is located between the left atrium and the leftventricle of the heart. During normal operation, the mitral valve opensduring diastole, allowing blood to flow from the left atrium into theleft ventricle. During systole, the mitral valve closes, causing highpressure blood to exit the left ventricle through the aorta. Mitralvalve regurgitation is a cardiac condition in which the posteriorleaflet of the mitral valve does not fully contact the anterior leafletof the valve during systole, thus a gap remains between the leaflets ofthe mitral valve during systole. The gap remaining between the leafletsallows retrograde blood flow to pass from the left ventricle into theleft atrium through the mitral valve. Thus, mitral regurgitation reducesthe volume of blood pumped out of the heart to the aorta during eachcardiac cycle, thus reducing the efficiency of the heart. Mitralregurgitation may exist for any of several reasons, including congenitalmalformations of the valve, ischemic disease, or effects ofcardiomyopathy, such as dilated (congestive) cardiomyopathy (i.e.,enlarging of the heart).

Conventional techniques for treating dysfunctions of the mitral valvetypically include highly invasive, open heart surgical procedures inorder to replace or repair the dysfunctioning mitral valve. Somesurgical procedures include the implantation of a replacement valve(e.g., animal valve or artificial mechanical valve). Other techniquesinclude the use of annuloplasty rings which are surgically placed aroundthe annulus of the mitral valve within the chamber of the heart andsutured into place. The presence of the annuloplasty ring alters thegeometry of the annulus of the mitral valve in order to improvecoaptation of the leaflets of the valve. Another surgical techniquewhich requires accessing one or more chambers of the heart is leafletcoaptation. Leaflet coaptation (e.g., Alfieri edge-to-edge repair) is asurgical procedure in which the valve leaflets are sutured together(e.g., bow-tie suture) to improve coaptation of the leaflets. A furthersurgical technique includes extending a tensioning cord across a chamberof the heart to alter the geometry of the heart chamber. The tensioningcord, which extends through a chamber of the heart, and thus is incontact with blood in the heart chamber, pulls opposing walls of theheart toward one another to reduce heart wall tension and/or repositionthe papillary muscles within the chamber. These techniques typicallyrequire opening the heart and/or entering one or more of the chambers ofthe heart to gain direct access to the mitral valve.

Therefore, it is desirable to devise a less invasive technique fortreating mitral valve regurgitation. Namely, it is desirable to devise apassive device which may be positioned exterior of the heart to alterthe geometry of the annulus of the mitral valve without the need to gainaccess to the interior of the heart. Thus, the device may be placed incontact with the epicardial surface of the heart without being incontact with blood within the heart.

SUMMARY

The disclosure is directed to several alternative designs, materials andmethods of manufacturing medical device structures and assemblies.

Accordingly, one illustrative embodiment is an epicardial clip forreshaping the annulus of the mitral valve of a heart, the mitral valvelying in a plane between the left atrium and the left ventricle of theheart. The epicardial clip includes a curved member having a first endand a second end. The member forms an anterior segment configured to bepositioned in the transverse sinus of the heart, a posterior segmentconfigured to be positioned on the posterior side of the heart, such ason or inferior to the atrioventricular groove or in the oblique sinus ofthe heart, and a lateral segment extending between the anterior segmentand the posterior segment. The lateral segment includes a curve, e.g.,helical, such that the first end of the member is positioned above theplane of the mitral valve and the second end of the member is positionedbelow the plane of the mitral valve. The transverse sinus is apericardial cavity of the heart located posterior to the aorta andpulmonary trunk and anterior to the left atrium, the atrioventriculargroove is the natural junction between the left atrium and the leftventricle on the posterior of the heart, and the oblique sinus is ablind pericardial cavity posterior of the heart.

Another illustrative embodiment is an epicardial clip for reshaping theannulus of the mitral valve of a heart, the mitral valve lying in aplane between the left atrium and the left ventricle of the heart. Theclip includes a curved member having a first end and a second end. Themember includes an anterior segment positioned superior to the plane ofthe mitral valve, a posterior segment positioned inferior to the planeof the mitral valve, and a lateral segment extending between theanterior segment and the posterior segment. The lateral segment includesa curve, e.g., helical, extending around a lateral portion of the heart.

Yet another illustrative embodiment is an epicardial clip for reshapingthe annulus of the mitral valve of a heart. The clip may have a complexgeometry which may be defined in an imaginary coordinate system. Thecoordinate system has an origin, an x-axis extending from the origin, ay-axis extending from the origin and perpendicular to the x-axis, and az-axis extending from the origin and perpendicular to both the x-axisand the y-axis. The clip includes a curved member having a first end anda second end. The curved member forms an anterior segment, a posteriorsegment and a lateral segment extending between the anterior segment andthe posterior segment. As a point of reference, the first end of themember is positioned at the origin of the imaginary coordinate system.The anterior segment begins at the origin and extends in the positivex-direction along the x-axis. The lateral segment, which extends fromthe anterior segment, includes a straight portion extending in thepositive y-direction and a curve portion extending to the posteriorsegment. The posterior segment extends from the lateral segment in thenegative x-direction. The posterior segment may generate a coordinatechange in the x-direction, a coordinate change in the y-direction, and acoordinate change in the z-direction. Furthermore, the lateral segmentmay generate a coordinate change in the z-direction between the anteriorsegment and the posterior segment.

The above summary of some example embodiments is not intended todescribe each disclosed embodiment or every implementation of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is a perspective view of an exemplary epicardial clip positionedin an imaginary box;

FIG. 2A is a top view of the epicardial clip of FIG. 1;

FIG. 2B is a side view of the epicardial clip of FIG. 1;

FIG. 3A shows the epicardial clip of FIG. 1 in an imaginarythree-dimensional x-y-z coordinate system;

FIG. 3B is a two-dimensional view of the epicardial clip toward the x-yplane of the three-dimensional coordinate system of FIG. 3A;

FIG. 3C is a two-dimensional view of the epicardial clip toward the x-zplane of the three-dimensional coordinate system of FIG. 3A;

FIG. 3D is a two-dimensional view of the epicardial clip toward the y-zplane of the three-dimensional coordinate system of FIG. 3A;

FIG. 4A is a top view of another exemplary epicardial clip;

FIG. 4B is a side view the epicardial clip of FIG. 4A;

FIG. 4C is a cross-sectional view of the epicardial clip of FIG. 4Ataken along line 4C-4C;

FIG. 5 is an illustration of select anatomical features of a heart;

FIG. 6A is an anterior view of a heart showing an exemplary position ofan epicardial clip;

FIG. 6B is a posterior view of a heart showing an exemplary position ofan epicardial clip;

FIG. 7 is a top view of the ventricular portion of a heart with theatria removed illustrating an exemplary position of an epicardial clip;

FIGS. 8A-8C are illustrative views showing the orientation of the planeof the mitral valve relative to the position of the epicardial clip on aheart;

FIGS. 9-15 show further embodiments and alternative configurations ofexemplary epicardial clips;

FIG. 16 is a top view of another exemplary epicardial clip;

FIG. 17 is a side view of the epicardial clip of FIG. 16 taken alongline 17-17;

FIG. 18 is a side view of the epicardial clip of FIG. 16 taken alongline 18-18;

FIGS. 19 and 20 are perspective views of yet another illustrativeepicardial clip;

FIG. 21 is a top view of the epicardial clip shown in FIGS. 19 and 20;

FIG. 21A is a top view illustrating exemplary curvatures and dimensionsof an epicardial clip;

FIG. 22 is a perspective view of the epicardial clip shown in FIGS. 19and 20 with the anterior segment rotated;

FIGS. 23A-23C are side views of the epicardial clip shown in FIGS. 19and 20 showing various possible rotated positions of the anteriorsegment;

FIG. 24 is a superior view of a heart in which the epicardial clip ofFIGS. 19 and has been positioned on;

FIGS. 25-29 are alternative configurations of the epicardial clip shownin FIGS. 19 and 20;

FIG. 30 shows the epicardial clip of FIGS. 19 and 20 with a flap ofmaterial disposed on the posterior segment;

FIGS. 31-34 illustrate further modification of the epicardial clip ofFIGS. 19 and 20;

FIGS. 35-38 illustrate exemplary embodiments of a sizing device whichmay be used to determine the correct size, shape and/or orientation ofan epicardial clip disclosed herein;

FIGS. 39A and 39B illustrate additional embodiments of an epicardialclip; and

FIGS. 40-44 illustrate an exemplary method of positioning an epicardialclip on a heart.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit aspects of the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the term “about” may be indicative asincluding numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

Although some suitable dimensions, ranges and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

As used in the specification and the appended claims, the term“anterior” is used in its anatomical sense to mean “toward the front, infront of, or the front surface of.”

As used in the specification and the appended claims, the term“posterior” is used in its anatomical sense to mean “toward the back, inback of, or the back surface of.”

As used in the specification and the appended claims, the term“superior” is used in its anatomical sense to mean “above, over top of,directed upward or toward the head.”

As used in the specification and the appended claims, the term“inferior” is used in its anatomical sense to mean “below, underneath,directed downward or toward the feet.”

As use in the specification and the appended claims, the term “lateral”is used in its anatomical sense to mean “a position or direction fartherfrom the sagittal or median plane or midline of the body, to the sideof, or the side surface of.”

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The detailed description and the drawings, which are notnecessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the invention. The illustrativeembodiments depicted are intended only as exemplary. Selected featuresof any illustrative embodiment may be incorporated into an additionalembodiment unless clearly stated to the contrary.

Now turning to the figures, an epicardial clip 10 is shown in FIG. 1.The epicardial clip 10 is depicted in an imaginary box 50 in order tofurther describe the three-dimensional geometry of the epicardial clip10. Additionally, two imaginary planes 53, 55 are shown in the imaginarybox 50 in order to further illustrate the geometry of the epicardialclip 10. The epicardial clip 10 may include a curved member 12 having afirst end 14 and a second end 16. In some embodiments the curved member12 may be a wire, bar, rod, strap, or the like. In some embodiments, theepicardial clip 10 may be formed of a single continuous wire, or theepicardial clip 10 may include a plurality of wires interconnected. Thecurved member 12 includes an anterior segment 20 proximate the first end14, a posterior segment 24 proximate the second end 16, and a lateralsegment 22 intermediate the anterior segment 20 and the posteriorsegment 24. In other words, the lateral segment 22 is located betweenthe anterior segment 20 and the posterior segment 24 of the member 12.As shown in FIG. 1, in some embodiments the anterior segment 20 mayinclude a straight portion, the posterior segment 24 may include acurved or arced portion, and/or the lateral segment 22 may include acurved portion, e.g., a helical portion, connecting the anterior segment20 and the posterior segment 24. In some embodiments, the anteriorsegment 20 may include a curved portion and/or the posterior segment 24may include a straight segment. The shape (e.g., curvature) of thesegments of the member 12 may be chosen such that the curvature of themember 12 contours the approximate shape of the heart. In someembodiments, the member 12 may be formed of a flexible material, suchthat the curvature of the member 12 may be altered as needed during amedical procedure to correspond to the anatomical shape of a patient'sheart and/or allowing deformation around an anatomical region of theheart. In other embodiments, the member 12 may be formed of anon-flexible or rigid material, having a permanent curvature which maynot be readily bent to an ad hoc curvature.

The member 12 may be formed of any suitable material. For example, themember 12 may be made from a metal, metal alloy, polymer, ametal-polymer composite, combinations thereof, and the like, or anyother suitable material. Some examples of suitable metals and metalalloys include stainless steel, such as 304V, 304 L, and 316 L stainlesssteel; mild steel; titanium alloys including titanium alpha-beta alloys,such as 6AL-4V (e.g., UNS: R56400); nickel-titanium alloy such aslinear-elastic and/or super-elastic nitinol; other nickel alloys such asnickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titaniumalloys; combinations thereof, and the like; or any other suitablematerial.

Some examples of suitable polymers may include fluorinated ethylenepropylene (FEP), polyoxymethylene (POM, for example, DELRIN® availablefrom DuPont), polyether block ester, polyurethane, polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), high-density polyethylene, low-densitypolyethylene, polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polyetheretherketone (PEEK), polyimide (PI),biocompatible polymers, other suitable materials, or mixtures,combinations, copolymers thereof, polymer/metal composites, and thelike.

FIG. 2A is a top view of the clip 10 taken with respect to theorientation of the clip 10 shown in FIG. 1. The view shown in FIG. 2A istaken looking directly down toward the top 52 of the imaginary box 50shown in FIG. 1 and showing the imaginary plane 53. As shown in FIG. 2A,the clip 10 may have a generally U-shape or C-shape when viewed withthis orientation. The clip 10 may be shaped such that the distanceacross the clip 10 between the anterior segment 20 and the posteriorsegment 24 is closest between the first end 14 of the member 12 and thesecond end 16 of the member 12. As discussed later herein, the distancebetween the first end 14 and the second end 16 may determine the finalanterior-posterior diameter of the mitral valve. The anterior segment 20may be substantially straight, and thus capable of residing in thetransverse sinus of the heart. The posterior segment 24 may be arcuate,corresponding to the semi-circular curvature of the posteriorventricular wall of the heart. The lateral segment 22 may have a helicalcurvature routing around the left lateral side of the heart, placing theanterior segment 20 in the transverse sinus and the posterior segment 24on the posterior of the heart, such as on or inferior to theatrioventricular groove or in the oblique sinus of the heart. In someembodiments, the radius of curvature of the lateral segment 22 may be inthe range of about 5 to about 70 millimeters, or in the range of about30 to about 46 millimeters, for example, about 10 millimeters, about 20millimeters, about 30 millimeters, about 40 millimeters, about 50millimeters, about 60 millimeters, about 70 millimeters, or otherdesired radius of curvature such that the lateral segment 22 may beproperly positioned around a lateral side of a heart. In someembodiments the lateral segment 22 may be routed around, over and/orunder the left atrial appendage of the heart. In other embodiments, thelateral segment 22 may be routed over the left atrium of the heart.

FIG. 2B is a side view of the clip 10 taken with respect to theorientation of the clip 10 shown in FIG. 1. The view shown in FIG. 2B istaken looking directly toward the front side 54 of the imaginary box 50shown in FIG. 1 and showing the imaginary planes 53 and 55. As shown inFIG. 2B, the anterior segment 20 may lie in an imaginary plane and theposterior segment 24 may lie in an imaginary plane. The imaginary planeof the posterior segment 24 may be located at an acute angle to theimaginary plane of the anterior segment 20. In some embodiments, thecurvature of the lateral segment 22, such as helical geometry of thelateral segment, may control the angle θ between the anterior segment 20and the posterior segment 24. For example, in some embodiments the angleθ may be in the range of about 5 to about 20 degrees, for example, about5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, or anyother suitable angle. Thus, the three-dimensional configuration of theclip 10 means that the clip 10 does not necessarily lie in a singleimaginary plane.

FIGS. 3A-3D show the clip 10 placed in a coordinate system having anorigin O, an x-axis extending from the origin O, a y-axis extending fromthe origin O and perpendicular to the x-axis, and a z-axis extendingfrom the origin O and perpendicular to both the x-axis and the y-axis.FIG. 3A shows the clip 10 in the three-dimensional x-y-z coordinatesystem. FIGS. 3B-3D show two-dimensional views of the clip 10 in each ofan x-y coordinate system, an x-z coordinate system, and a y-z coordinatesystem. FIG. 3B is a view looking directly at the x-y plane (i.e., aplane passing through both the x-axis and the y-axis). FIG. 3C is a viewlooking directly at the x-z plane (i.e., a plane passing through boththe x-axis and the z-axis). FIG. 3D is a view looking directly at they-z plane (i.e., a plane passing through both the y-axis and thez-axis).

As shown in relation with the coordinate system with the first end 14 ofthe member 12 positioned at the origin O, the anterior segment 20extends in the x-direction (e.g., positive x-direction) along thex-axis. The anterior segment 20 may lie in the x-y plane of thecoordinate system. The lateral segment 22, which may include a curve,such as a helical curve, extends from the anterior segment 20, and maygenerate a coordinate change in the z-direction (e.g., negativez-direction) between the anterior segment 20 and the posterior segment24. The posterior segment 24 extends from the lateral segment 22 andgenerates a coordinate change in the x-direction (e.g., negativex-direction), a coordinate change in the y-direction (e.g., negativey-direction), and a coordinate change in the z-direction (e.g., negativez-direction). Thus, the posterior segment 24 does not lie in the x-yplane, the x-z plane, or the y-z plane of the coordinate system. Thus,the member 12 may include components which extend in each of thex-direction, the y-direction, and the z-direction, and does not lie in asingle plane. In some embodiments, the lateral segment 22, extendingfrom the anterior segment 20, may include a straight portion extendingin the y-direction (e.g., positive y-direction) and a curve portionextending to the posterior segment.

FIGS. 4A and 4B show another embodiment of an epicardial clip 110. Theepicardial clip 110 may include a curved member 112 (see also FIG. 4C),such as a wire or strap, similar to the curved member 12 of FIG. 1. Thecurved member 112 may have substantially the same shape and curvature asthe member 12 of FIG. 1, thus, additional discussion of the curvature ofthe member 112 is not necessary.

As shown in FIG. 4C, which is a cross-section of the clip 110 throughline 4C-4C of FIG. 4A, the clip 110 includes a curved member 112surrounded by or encased within an outer covering 130. In someembodiments, the outer covering 130 may cover one or more of theanterior segment 20, the posterior segment 24 and/or the lateral segment22. For example, the outer covering 130 may cover the posterior segment24 and the lateral segment 22, while the anterior segment 20 is notencased with the outer covering 130. In some embodiments the outercovering 130 may be an atraumatic, bioabsorbable and/or biocompatiblecovering. For example, in some embodiments the outer covering 130 may bea compliant material, for example a polymeric over-mold, such as asilicone over-mold. The outer covering 130, which may be at leastpartially formed of a compliant material, may more evenly distributestresses from the member 112 to the surface of the heart, preventlateral motion of the clip 110 positioned on the heart, and/or providean area for securing the clip 110 to the heart. For instance, in someembodiments the outer covering 130 may distribute clamping forces toavoid occluding arteries and/or veins on the myocardium and/orepicardium. In some embodiments the outer covering 130 may providesufficient torsional flexibility, allowing the clip 110 to conform tothe contours of the heart.

The outer covering 130 may include a rounded or bulbous section 132 onthe anterior segment 120, and a flat section 134 on the posteriorsegment 124. The bulbous section 132 may prevent lateral motion of theclip 110 when positioned on the heart and may distribute stresses moreuniformly in the transverse sinus, as discussed later herein. In someembodiments the anterior segment 120, including the bulbous section 132,may be shaped to preserve the hemodynamics of the great vessels (e.g.,aorta, pulmonary trunk, superior vena cava) and aid in retention of theanterior segment 120 in the transverse sinus. The flat section 134 mayform to the contours of the heart and/or may more uniformly distributeforces exerted by the clip 110 on the posterior of the heart. Forexample, the flat section 134 may conform around vessels on theepicardial surface of the heart to avoid occluding the vessels.

Also shown in FIG. 4C, in some embodiments the outer covering 130 mayinclude and/or be wrapped in a fabric sheath 133. For example, in someembodiments the fabric sheath 133 may be an ePTFE material, a polyesterknitted fabric, a polyester velour, a polypropylene felt, a woven orbraided fabric, a non-woven fabric, porous material, or other textilematerial, as desired. The fabric sheath 133 may promote tissue in-growthon the epicardial surface of the heart, may provide tissue in-growthinto interstices of the fabric sheath 133, and/or provide adequatefrictional forces (traction) to hold the clip 110 in contact with theheart and prevent migration of the device once positioned on the heart.Tissue in-growth therein and/or thereon may provide long-term retentionof the clip 110 in a desired position on the heart and prevent erosion.

In some embodiments, the clip 110 may include a drug eluting coating inaddition to or as an alternative to the outer covering 130. The drugeluting coating may a controlled release of a therapeutic agent over aspecified period of time. The therapeutic agent may be any medicinalagent which may provide a desired effect. Suitable therapeutic agentsinclude drugs, genetic materials, and biological materials. Somesuitable therapeutic agents which may be loaded in the drug elutingcoating include, but are not necessarily limited to, antibiotics,antimicrobials, antioxidants, anti-arhythmics, cell growth factors,immunosuppressants such as tacrolimus, everolimus, and rapamycin(sirolimus), therapeutic antibodies, wound healing agents, therapeuticgene transfer constructs, peptides, proteins, extracellular matrixcomponents, steroidal and non-steroidal anti-inflammatory agents,anti-proliferative agents such as steroids, vitamins and restenosisinhibiting drugs, such as Taxol®, paclitaxel (i.e., paclitaxel,paclitaxel analogues, or paclitaxel derivatives, and mixtures thereof).

FIGS. 4A and 4B are a top view and a side view, respectively, of theclip 110 in the same orientation as that of the clip 10 shown in FIGS.2A and 2B. Thus, as can be seen in FIG. 4A, the clip 110 may have asubstantially U-shape or C-shape. In some embodiments, the distanceacross the clip 10 between the anterior segment 120 and the posteriorsegment 124 is closest between the first end 114 of the member 112 andthe second end 116 of the member 112. The distance between the first end114 and the second end 116 may determine the final anterior-posteriordiameter of the mitral valve.

As shown in FIG. 4B, the anterior segment 120 may lie in an imaginaryplane and the posterior segment 124 may lie in an imaginary plane. Theimaginary plane of the posterior segment 124 may be located at an acuteangle θ to the imaginary plane of the anterior segment 120. Thegeometry, such as helical geometry, of the lateral segment 122 maycontrol the angle θ between the anterior segment 120 and the posteriorsegment 124. Thus, the curvature, such as a helical curvature, of thelateral segment 122 may ensure that the anterior segment 120 is properlypositioned in the transverse sinus while the posterior segment 124 isproperly positioned on the posterior of the heart, such as on orinferior to the atrioventricular groove or in the oblique sinus of theheart.

A heart H, illustrated as a human heart, is shown in FIG. 5. The heart His viewed from the anterior side at a slightly superior position. Thechambers of the heart H include the left ventricle LV, the left atriumLA, the right ventricle RV, and the right atrium RA. Also shown are thepulmonary trunk PT, the aorta A, the superior vena cava SVC, the rightpulmonary veins RPV, the left pulmonary veins LPV, and the left atrialappendage LAA. The transverse sinus TS is also referenced in FIG. 5. Thetransverse sinus TS is a pericardial cavity between the pericardium Pand the epicardial surface of the heart H located posterior to the aortaA and the pulmonary trunk PT and anterior to the left atrium and thesuperior vena cava SVC.

The pericardial sac or pericardium P, which is a tissue membranecovering the epicardial surface of the heart H, is also shown removedfrom the heart H in FIG. 5 to further illustrate noteworthy anatomy ofthe heart H. The oblique sinus OS is a blind (e.g., cul-de-sac) recesson the posterior of the heart H formed between the pericardium P and theepicardial surface of the heart H. The oblique sinus OS lies generallybetween the right pulmonary veins and RPV and the left pulmonary veinsLPV, with the thoracic part of the inferior vena cava IVC located to theright of the oblique sinus OS. Only two layers of serous pericardiumseparate the transverse sinus TS and the oblique sinus OS.

The clip 10 may be positioned on the epicardial surface of the heart Hduring a medical procedure. For example, in some embodiments the clip 10may be installed on the heart H during a beating heart surgery, withoutthe need of a heart/lung bypass machine. For instance, the clip 10 maybe implanted on the heart H through an open chest procedure (stemotomy)or a lateral thorocotomy. In some embodiments, the clip 10 may bepositioned on the heart H through a less-invasive endoscopic approach.

For instance, during a sternotomy, the thoracic cavity may be accessedfor direct visual placement of the clip 10 on the beating heart H. Thepericardium P may be incised to access the pericardial cavity betweenthe pericardium P and the epicardial surface of the heart H. Uponaccessing the pericardial cavity, the clip 10 may be properly positionedon the epicardial surface of the heart H. The anterior segment 20 may bepositioned in the transverse sinus TS posterior to the aorta A and thepulmonary trunk PT and anterior to the left atrium and the superior venacava SVC. Thus, the first end 14 of the member 12 may be located in thetransverse sinus TS. The posterior segment 24 may be positioned on theposterior side of the heart H, such as on or inferior to theatrioventricular groove AVG (shown in FIG. 6B) or in the oblique sinusOS. Thus, the second end 16 of the member 12 may be located on orinferior to the atrioventricular groove AVG or in the oblique sinus OS.In some embodiments, the posterior segment 24 may be positioned inferiorto the atrioventricular groove on the posterior side of the heart H. Thelateral segment 22 may extend around the left lateral side of the heartH such that the anterior segment 20 is properly positioned in thetransverse sinus TS while the posterior segment 24 is properlypositioned on the posterior side of the heart H, such as on or inferiorto the atrioventricular groove AVG or in the oblique sinus OS. In someembodiments, the lateral segment 22 may extend around the heart H at alocation inferior to the left atrial appendage LAA. However, in otherembodiments the lateral segment 22 may extend around the heart H at alocation superior to the left atrial appendage LAA or over the leftatrium LA to join the anterior segment 20 and the posterior segment 24.

The clip 10, when properly positioned, may reside on the epicardialsurface of the heart H, interior of the pericardium P. Thus, positioningof the clip 10 may not require penetration of the heart into one or moreof the chambers of the heart and/or may not require the clip 10 to comeinto contact with blood being located inside the chambers of the heart.By placing the clip 10 on the epicardial surface, exterior of theinterior of the heart H, complications associated with surgicalprocedures in which access is required to one or more of the chambers ofthe heart H are avoided. Furthermore, the time required to complete thesurgical procedure may be greatly reduced from the time required for anopen heart surgery or a surgical procedure requiring accessing the heartthrough the vasculature.

In some embodiments, the distance between the first end 14 and thesecond end 16 of the member 12 may be altered during the medicalprocedure in order to adjust the coaptation of the leaflets of themitral valve MV. By adjusting the distance between the first end 14 andthe second end 16 of the member 12, or otherwise adjusting the curvatureof the member 12, the amount of force applied to the walls of the heartH may be varied to attain the response on the mitral valve MV desired.In some embodiments, a sizing device may initially be used to determinethe desired curvature of the clip 10, and then a clip 10 of the propercurvature may be chosen, or the clip 10 may be formed to the propercurvature to attain the desired results to the mitral valve MV.Echocardiographic images may be taken to determine the optimal ordesired position and/or curvature of the clip 10.

FIG. 6A is an anterior view of the heart H, with the clip 10 placed onthe epicardial surface of the heart H. As shown in FIG. 6A, the anteriorsegment 20 of the clip 10 is positioned in the transverse sinus TSposterior to the aorta A and the pulmonary trunk PT and anterior to theleft atrium and the superior vena cava SVC. The lateral segment 22 mayextend around the left lateral side of the heart H at a locationinferior to the left atrial appendage LAA. In other embodiments, thelateral segment 22 may extend around the left lateral side of the heartH at a location superior to the left atrial appendage LAA or over theleft atrium LA.

FIG. 6B is a posterior view of the heart H with the clip 10 placed onthe epicardial surface of the heart H. As shown in FIG. 6B, theposterior segment 24 of the clip 10 is positioned on the posterior ofthe heart H inferior of the atrioventricular groove AVG. The posteriorsegment 24 may be positioned such that it is just below the circumflexartery CX. In other embodiments, the posterior segment 24 may bepositioned such that it is just above the circumflex artery CX.

When the clip 10 is properly positioned with the anterior segment 20located in the transverse sinus TS and the posterior segment 24 locatedin the oblique sinus OS, the clip 10 may apply an inward pressure on thewalls of the heart H. The inward pressure exerted by the clip 10 mayalter the geometry of the annulus of the mitral valve located betweenthe left atrium LA and the left ventricle LV, thus reducing theanterior-posterior distance across the mitral valve MV and/or theseptal-lateral distance across the mitral valve MV. The proper inwardpressure may be determined, for example with echocardiographic images,to optimize the functionality of the mitral valve MV to reduce oreliminate mitral regurgitation.

FIG. 7 is a top view of the ventricular portion of the heart H with theatria removed. With the atria removed, the mitral valve MV between theleft atrium LA and the left ventricle LV may be clearly viewed. FIG. 7also shows the tricuspid valve TV between the right atrium RA and theright ventricle RV, as well as the aortic valve AV leading to the aortaA and the pulmonary valve PV leading to the pulmonary trunk PT. As shownin FIG. 7, the mitral valve MV includes two leaflets, an anteriorleaflet AL and a posterior leaflet PL. The mitral valve MV is shownclosed as it would be during systole. The clip 10 is shown in dashedlines in FIG. 8 as the clip 10 may not lie in the plane of the mitralvalve MV.

As shown in FIG. 7, when the clip 10 is properly placed around theheart, the shape of the clip 10 may reduce the anterior-posteriormeasurement of the mitral valve MV. In other words, the clip 10 may urgethe posterior leaflet PL of the mitral valve MV toward the anteriorleaflet AL, providing better contact (coaptation) of the anterior andposterior valve leaflets of the mitral valve MV, which may reduce oreliminate mitral regurgitation. For instance, the posterior segment 24of the clip 10 may push on the ventricular wall of the left ventricle LVto alter the diameter of the annulus of the mitral valve MV. Thus, asshown in FIG. 7, the inclusion of the clip 10 may allow the posteriorleaflet PL to more fully contact the anterior leaflet AL during systoleto reduce or prevent retrograde blood flow through the mitral valve MV,thereby increasing the efficiency of the heart. During a medicalprocedure, echocardiographic images may be taken to determine theoptimal or desired position and/or curvature of the clip 10 to attainthe proper anterior-posterior measurement (distance) and/orseptal-lateral measurement (distance) of the annulus of the mitral valveMV to minimize and/or eliminate mitral regurgitation.

FIGS. 8A-8C show the clip 10 as oriented with the plane of the mitralvalve MV when the anterior segment 20 of the clip 10 is positioned inthe transverse sinus TS and the posterior segment 24 of the clip 10 ispositioned on the posterior side of the heart, such as on or inferior tothe atrioventricular groove. As mentioned previously, the mitral valveMV lies in an imaginary plane which is shown in FIGS. 8A-8C as plane 90.When positioned on the epicardial surface of the heart H, the anteriorsegment 20 extends above the plane of the mitral valve MV and theposterior segment 24 extends below the plane of the mitral valve MV.Thus, neither the anterior segment 20 nor the posterior segment 24 liesin the same plane as the mitral valve MV. Furthermore the imaginary linebetween the first end 14 of the clip 10 and the second end 16 of theclip 10 does not lie in the plane of the mitral valve MV. As shown inFIGS. 8A-8C, the plane of the mitral valve MV intersects the lateralsegment 22 of the clip 10.

Further embodiments of alternative configurations of epicardial clipswith various modifications and additional features are shown in FIGS.9-15. The epicardial clip 210 shown in FIG. 9 includes an additional orsecondary curve 240 in the anterior segment 220 of the curved member212. The secondary curve 240 may curve anteriorly in order to extend outaround the aorta A when the anterior segment 220 is positioned in thetransverse sinus TS posterior to the aorta A. Thus, the secondary curve240 may aid in greater device stability and/or retention in thetransverse sinus TS, preventing migration of the clip 210 during the useof the clip 210 on the heart H.

The epicardial clip 210 also includes a tighter curve 242 (e.g. a radiusof curvature less than the radius of curvature of the remainder of theposterior segment 224) in the posterior segment 224 of the member 212.The curve 242 is located at the second end 216 of the member 212. Thecurve 242 increases the inward force on the ventricular wall in thisregion to provide an extra push in the A3-P3 region of the mitral valveMV.

The epicardial clip 210 is shown with a pad 244 disposed over at least aportion of the posterior segment 224. The pad 244 may help distributeforces from the epicardial clip 210 over a larger portion of theventricular wall of a heart. For example, the pad 244 of the epicardialclip 210 may prevent or reduce contact forces being applied to a vessellocated on the epicardial surface of the heart.

The epicardial clip 310 shown in FIG. 10 includes an anterior segment320, a posterior segment 324 and a lateral segment 322 between theanterior segment 320 and the posterior segment 324. The epicardial clip310 also includes an anterior pad 330 positioned over the anteriorsegment 320 of the member 312, and a posterior pad 334 positioned overthe posterior segment 324 of the member 312. The anterior pad 330 mayhelp retain the anterior segment 320 in the transverse sinus and preventmigration of the clip 310. The posterior pad 324, which may be a flatpad in some embodiments, may distribute forces over a greater area ofthe ventricular wall without occluding vessels in the myocardium.

The epicardial clip 410 shown in FIG. 11 includes an anterior segment420 proximate a first end 414 of the member 412, a posterior segment 424proximate a second end 416 of the member 412, and a lateral segment 422between the anterior segment 420 and the posterior segment 424. Theepicardial clip 410 also includes three posterior pads 444 located atspaced intervals along the posterior segment 424 of the member 412. Theposterior pads 444 may include apertures for receiving sutures,fasteners or tissue anchors, such that the posterior pads 444 may besutured or anchored to the ventricular wall of the heart.

The epicardial clip 410 also includes a bulbous tip 432 on the anteriorsegment 420 at the first end 414 of the member 412. The bulbous tip 432may be shaped to preserve the hemodynamics of the great vessels (e.g.,aorta, pulmonary trunk, superior vena cava) and aid in retention of theanterior segment 420 in the transverse sinus.

Furthermore, the epicardial clip 410 includes a tighter curve 442located between the anterior segment 420 and the lateral segment 422.The curve 442 may have a radius of curvature less than the radius ofcurvature of the lateral segment 422. The curve 442 increases the inwardforce on the atrial wall in this region to provide an extra push in theA1-P1 region of the mitral valve.

The epicardial clip 510 shown in FIG. 12 includes an anterior segment520, a posterior segment 524, and a lateral segment 522 between theanterior segment 520 and the posterior segment 524. The epicardial clip510 also includes a plurality of balloons 540 positioned on the member512. The balloons 540 may be selectively inflated to provide a desiredamount of force at desired locations of the epicardial surface of theheart. In some embodiments, the balloons 540 may each be individually orcollectively inflated to a desired size. In some embodiments, theballoons 540 may be independently, simultaneously, and/or successivelyinflated. The balloons 540 may be inflated by one or more conduits 532which may be permanently attached to the balloons 540, or the one ormore conduits 532 may be detachable from the balloons 540 upon properinflation of the balloons 540.

The balloons 540 may provide an inward force at a desired location toprovide better coaptation of the valve leaflets. For instance, theposterior segment 524 may include three balloons 540. The balloon 540 amay provide a desired inward push in the A3-P3 region of the mitralvalve, the balloon 540 b may provide a desired inward push in the A2-P2region of the mitral valve, and the balloon 540 c may provide a desiredinward push in the A1-P1 region of the mitral valve. The balloon 540 don the anterior segment 520 may also provide a desired push in the A1-P1region and/or the balloon 540 d may aid in retaining the anteriorsegment 520 in the transverse sinus.

The epicardial clip 610 shown in FIG. 13 includes an anterior segment620, a posterior segment 624, and a lateral segment 622 between theanterior segment 620 and the posterior segment 624. The epicardial clip610 also includes an arm 646 extending from the member 612. When theepicardial clip 610 is properly positioned around the heart, the arm 646may push inward on the ventricular wall, exterior of the papillarymuscles of the left ventricle, to reduce the distance between thepapillary muscles in order to improve coaptation of the leaflets of themitral valve. In other embodiments, the epicardial clip 610 may includeone or more additional arms for pushing inward on the papillary muscles.For example an embodiment having two arms 646 may be used to squeeze orpush the papillary muscles in the left ventricle toward each other.

The pads 644 connected to the member 612 may also be used to anchor orsecure the clip 610 to the epicardial surface of the heart. Forinstance, the clip 610 may be sutured or anchored with tacking screws,or the like, to the myocardium to retain the clip 610 in a properorientation around the heart.

Another embodiment of an epicardial clip 710 is shown in FIG. 14. Theepicardial clip 710 is formed of a member 712 having an anterior segment720, a posterior segment 724, and a lateral segment 722 intermediate theanterior segment 720 and the posterior segment 724. The lateral segment722 is bent relative to both the anterior segment 720 and the posteriorsegment 724. Thus, the lateral segment 722 may lie in a plane dissimilarto the plane of the anterior segment 720 and the plane of the posteriorsegment 724. The shape of the lateral segment 722 may allow the lateralsegment 722 to be stabilized on a lateral portion of the ventricularwall of a heart.

Another epicardial clip 810 is shown in FIG. 15. The epicardial clip 810is formed of a member 812 having an anterior segment 820, a posteriorsegment 824, and a lateral segment 822 intermediate the anterior segment820 and the posterior segment 824. As shown in FIG. 15, the lateralsegment 822 includes a spring-like helical loop 826 providing the clip810 with a springy quality which allows the member 812 to recover itsoriginal shape when released after being distorted by an applied force.Thus, the ends 814 and 816 of the member 812 may be forced away fromeach other during insertion of the clip 810 on the heart, but the springnature of the helical loop 826 tends to draw the ends 814 and 816 backtoward each other when the applied force is removed from the member 812.

FIG. 16 is a top view of another configuration of an epicardial clip910. The epicardial clip 910, as shown in FIG. 16 is positioned as itwould appear to an observer looking down on a heart on which theepicardial clip 910 is placed, from a superior position. The epicardialclip 910 is formed of a member 912 having an anterior segment 920, aposterior segment 924, and a lateral segment 922 intermediate theanterior segment 920 and the posterior segment 924. The anterior segment920 is configured to be positioned on an anterior portion of the heart,the posterior segment 924 is configured to be positioned on a posteriorportion of the heart, and the lateral segment 922 is configured to bepositioned on a lateral portion of the heart. For example, when properlypositioned on the epicardial surface of a heart, the anterior segment920 may be positioned in the transverse sinus, the posterior segment 924may be positioned on the posterior side of the heart, such as on orinferior to the atrioventricular groove or in the oblique sinus, and thelateral segment 922 may extend around the lateral side of the heart inorder to allow proper placement of the anterior segment 920 and theposterior segment 924.

The epicardial clip 910 may include a plurality of sections. As shown inFIG. 16, the epicardial clip 910 includes seven sections, however, othernumbers and/or configurations of sections are contemplated. In someembodiments, the sections of the epicardial clip 910 may be alternatingsections of curved portions and straight portions of the epicardial clip910. The epicardial clip 910, as shown in FIG. 16, includes a firstsection 981 and a second section 982, which may span the posteriorsegment 924 of the epicardial clip 910. The first section 981 may be acurved section having a radius of curvature R₁ and a length L₁ whichgoes through an angle θ₁. In some embodiments, the radius of curvatureR₁ of the first section 981 may be in the range of about 1 inch to about2 inches, about 1.25 inches to about 1.75 inches, or about 1.5 inches,depending on the specific anatomical shape of the heart. The firstsection 981 may extend through an angle θ₁. In some embodiments, theangle θ₁ may be in the range of about 20° to about 40°, or about 30°. Insome embodiments, the length L₁ of the first section 981 may be in therange of about 0.5 inches to about 1.5 inches, about 0.75 inches toabout 1.0 inches, or about 0.785 inches. The curved nature of the firstsection 981 may allow it to conform to the curvature of the posteriorside of the heart.

The second section 982 may be a straight or substantially straightsection having a length L₂ in the range of about 0.4 to about 0.8inches, about 0.5 inches to about 0.7 inches, or about 0.5 inches.

The epicardial clip 910 may also include a third section 983, a fourthsection 984 and a fifth section 985, which may span the lateral segment922 of the epicardial clip 910. The third section 983 may be a curvedsection having a radius of curvature R₃ and a length L₃ which goesthrough an angle θ₃. In some embodiments, the radius of curvature R₃ ofthe third section 983 may be in the range of about 0.25 inch to about1.5 inches, about 0.5 inches to about 1.0 inches, or about 0.75 inches,depending on the specific anatomical shape of the heart. The thirdsection 983 may extend through an angle θ₃. In some embodiments, theangle θ₃ may be in the range of about 75° to about 130°, about 90° toabout 115°, or about 105°. In some embodiments, the length L₃ of thethird section 983 may be in the range of about 0.5 inches to about 2.0inches, about 1.0 inches to about 1.5 inches, or about 1.375 inches. Thecurved nature of the third section 983 may allow it to conform to thecurvature of the anterior side of the heart.

The fourth section 984 may be a straight or substantially straightsection having a length L₄ in the range of about 0.2 to about 0.5inches, about 0.3 inches to about 0.4 inches, or about 0.375 inches.

The fifth section 985 may be a curved section having a radius ofcurvature R₅ and a length L₅ which goes through an angle θ₅. In someembodiments, the radius of curvature R₅ of the fifth section 985 may bein the range of about 0.25 inches to about 0.75 inches, about 0.4 inchesto about 0.5 inches, or about 0.4625 inches, depending on the specificanatomical shape of the heart. The fifth section 985 may extend throughan angle θ₅. In some embodiments, the angle θ₅ may be in the range ofabout 75° to about 130°, about 90° to about 115°, or about 110°. In someembodiments, the length L₅ of the fifth section 985 may be in the rangeof about 0.5 inches to about 2.0 inches, about 0.75 inches to about 1.0inches, or about 0.888 inches. The curved nature of the fifth section985 may allow it to conform to the curvature of the anterior side of theheart.

Additionally, the epicardial clip 910 may include a sixth section 986and a seventh section 987, which may span the anterior segment 920 ofthe epicardial clip 910. The sixth section 986 may be a straight orsubstantially straight section having a length L₆ in the range of about0.5 inches to about 1.0 inches, about 0.6 inches to about 0.8 inches, orabout 0.75 inches.

The seventh section 987 may be a curved section having a radius ofcurvature R₇ and a length L₇ which goes through an angle θ₇. In someembodiments, the radius of curvature R₇ of the seventh section 987 maybe in the range of about 0.25 inches to about 0.75 inches, about 0.3inches to about 0.6 inches, or about 0.5 inches, depending on thespecific anatomical shape of the heart. The seventh section 987 mayextend through an angle θ₇. In some embodiments, the angle θ₇ may be inthe range of about 75° to about 120°, about 80° to about 100°, or about90°. In some embodiments, the length L₇ of the seventh section 987 maybe in the range of about 0.5 inches to about 1.25 inches, about 0.6inches to about 0.8 inches, or about 0.785 inches. The curved nature ofthe seventh section 983 may allow it to be positioned around a portionof the root of the aorta when the anterior segment 920 is positioned inthe transverse sinus of a heart in order to further anchor theepicardial clip 910 in the transverse sinus.

FIG. 17 is a side view of the epicardial clip 910 taken along the line17-17 of FIG. 16. As shown in FIG. 17, the epicardial clip 910 may havea helical nature. For instance, the lateral segment 922 may include oneor more helical curves such that the anterior segment 920 does not liein the same plane as the posterior segment 924. For example, the thirdsection 983 and/or the fifth section 985 of the epicardial clip 910 mayinclude a helical curve.

Additionally, as shown in FIG. 17, the seventh section 987 may be at anoblique angle θ₈ to the adjacent sixth section 986. For example, theseventh section 987 may be at an angle θ₈ of about 120° to about 170°,about 130° to about 16020 , or about 155° to the sixth section 986. Theangle θ₈ may allow the seventh section 987 to reside within thetransverse sinus of a heart.

FIG. 18 is a side view of the epicardial clip 910 taken along the line18-18 of FIG. 16. As shown in FIG. 18, the anterior segment 920 does notlie in the same plane as the posterior segment 924. For example, theanterior segment 920 may lie in an imaginary plane which is at an angleθ₉ to an imaginary plane in which the posterior segment 924 may lie. Forexample, the anterior segment 920 may be at an angle θ₉ of about 10° toabout 30°, about 20° to about 25°, or about 23.5° to the posteriorsegment 924. The angle θ₉ may allow the anterior segment 920 to bepositioned within the transverse sinus of a heart while allowing theposterior segment 924 to be positioned on the posterior side of theheart, such as on or inferior to the atrioventricular groove or withinthe oblique sinus of the heart, with the lateral segment 922 extendingaround a lateral portion of the heart.

FIGS. 19 and 20 are perspective views of yet another epicardial clip1010. The epicardial clip 1010 may include an anterior segment 1020, aposterior segment 1024, and a lateral segment 1022 intermediate theanterior segment 1020 and the posterior segment 1024. The anteriorsegment 1020 is configured to be positioned on an anterior portion ofthe heart, the posterior segment 1024 is configured to be positioned ona posterior portion of the heart, and the lateral segment 1022 isconfigured to be positioned on a lateral portion of the heart. Forexample, when properly positioned on the epicardial surface of a heart,the anterior segment 1020 may be positioned in the transverse sinus, theposterior segment 1024 may be positioned on the posterior side of theheart, such as on or inferior to the atrioventricular groove or in theoblique sinus, and the lateral segment 1022 may extend around thelateral side of the heart in order to allow proper placement of theanterior segment 1020 and the posterior segment 1024.

In some embodiments, the epicardial clip 1010 may include a core member(not shown), such as a wire or rod with an appropriate curvaturesurrounded by or encased within an outer member 1030. In someembodiments the outer member 1030 may be an atraumatic, bioabsorbableand/or biocompatible covering. For example, in some embodiments theouter member 1030 may be a compliant material, for example a polymericover-mold, such as a silicone over-mold molded, formed or otherwiseplaced around an inner core member. In some embodiments, the outermember 1030 may be an irregular shaped member complementary with thecontours of a heart. The outer member 1030 may more evenly distributestresses from the epicardial clip 1010 to the surface of the heart,prevent lateral motion of the clip 1010 positioned on the heart, and/orprovide an area for securing the clip 1010 to the heart. For instance,in some embodiments the outer member 1030, such as a silicone over-mold,may distribute clamping forces to avoid occluding arteries and/or veinson the myocardium. In some embodiments the outer member 1030 may providesufficient torsional flexibility, allowing the clip 1010 to conform tothe contours of the heart.

Additionally, although not shown, in some embodiments the outer member1030 may be wrapped in a fabric covering or sheath. In some embodiments,the fabric covering may be stitched, adhered, clipped or otherwisesecured to itself and/or the outer member 1030 to hold the fabriccovering in place. For example, in some embodiments the fabric coveringmay be an ePTFE material, a polyester knitted fabric, a polyestervelour, a polypropylene felt, a woven or braided fabric, a non-wovenfabric, porous material, or other textile material, as desired. In someembodiments, the fabric covering may promote tissue in-growth on theepicardial surface of the heart, may provide tissue in-growth intointerstices of the fabric sheath and/or provide adequate frictionalforces (traction) to hold the epicardial clip 1010 in contact with theheart and prevent migration of the device once positioned on the heart.Tissue in-growth therein and/or thereon may provide long-term retentionof the epicardial clip 1010 in a desired position on the heart andprevent erosion.

In some embodiments, the epicardial clip 1010 may include a drug elutingcoating in addition to or as an alternative to an outer member and/orfabric covering. The drug eluting coating may a controlled release of atherapeutic agent over a specified period of time. The therapeutic agentmay be any medicinal agent which may provide a desired effect. Suitabletherapeutic agents include drugs, genetic materials, and biologicalmaterials. Some suitable therapeutic agents which may be loaded in thedrug eluting coating include, but are not necessarily limited to,antibiotics, antimicrobials, antioxidants, anti-arhythmics, cell growthfactors, immunosuppressants such as tacrolimus, everolimus, andrapamycin (sirolimus), therapeutic antibodies, wound healing agents,therapeutic gene transfer constructs, peptides, proteins, extracellularmatrix components, steroidal and non-steroidal anti-inflammatory agents,anti-proliferative agents such as steroids, vitamins and restenosisinhibiting drugs, such as Taxol®, paclitaxel (i.e., paclitaxel,paclitaxel analogues, or paclitaxel derivatives, and mixtures thereof).

As can be seen in FIG. 21, when viewed from above, the epicardial clip1010 may have a generally U-shape or C-shape. The epicardial clip 1010may be a one-piece, unitary member, or the epicardial clip 1010 may beformed of two or more discrete elements coupled together. For example,as shown in FIG. 21, the posterior segment 1024 and the lateral segment1022 may be integrally formed, and the anterior segment 1020 may becoupled to the lateral segment 1022. For instance, the anterior segment1020 may include a coupling portion or coupler 1025 for coupling theanterior segment 1020 to the lateral segment 1022. In some embodimentsthe coupling portion 1025 may be a tubular member extending over aportion of the anterior segment 1020 and extending over a portion of thelateral segment 1022.

As shown in FIG. 21, the anterior segment 1020 may include adouble-member (e.g., a member that is bent back on itself, forming aU-shape). The double-member of the anterior segment 1020 may be found toprovide enhanced retention and/or stability in the transverse sinusduring use. The double-member of the anterior segment 1020 may include afirst arm 1041 and a second arm 1042, connected by a connecting portion1043, which may be a curved portion. In some embodiments the first arm1041 may be parallel to the second arm 1042, and the connecting portion1043 may be substantially perpendicular to each of the first arm 1041and the second arm 1042. It is noted that in some embodiments a portionof the second arm 1042 may extend into the coupling portion 1025 orotherwise be connected to the lateral segment 1022. In some embodiments,the curved portion of the anterior segment 1020 may have a curvaturenormal to the curvature of the lateral segment 1022. In someembodiments, the curved portion of the anterior segment 1020 may have acurvature normal to the plane of the mitral valve. In some embodiments,the anterior segment 1020 may substantially occupy the transverse sinusfrom the inferior aspect of the transverse sinus to the superior aspectof the transverse sinus. In some embodiments, the second arm 1042 may belocated on the floor of the transverse sinus, while the first arm 1041may anchor itself against the reflection of the pericardium thatseparates the transverse and oblique sinuses at the top of the atrium.

FIG. 21A illustrates some suitable dimensions of portions of theepicardial clip 1010. Although some suitable dimensions are indicatedfor the epicardial clip 1010, one of skill in the art, incited by thepresent disclosure, would understand that other embodiments disclosedherein, as well as additional conceivable embodiments, may includesimilar dimensions, if desired. For example, corresponding regions ofthe epicardial clip 10, 110, 210, 310, 410, 510, 610, 710, and 810 maybe similarly dimensioned in some embodiments.

As shown in FIG. 21A, the anterior segment 1020, which may be a straightsegment of the epicardial clip 1010, may have a length L₁ in the rangeof about 1 to about 3 inches, in the range of about 1 to about 2.5inches, in the range of about 1.25 to about 2 inches, or in the range ofabout 1.28 to about 2.07 inches in some instances. In other embodiments,the anterior segment 1020 may be a curved segment having an arc lengthin the range of about 1 to about 3 inches, in the range of about 1 toabout 2.5 inches, in the range of about 1.25 to about 2 inches, or inthe range of about 1.28 to about 2.07 inches in some instances.

The epicardial clip 1010 may have an anterior/lateral curve segment 1021defining a transition region between the anterior segment 1020 and thelateral segment 1022. In some embodiments, the anterior/lateral curvesegment 1021 may be considered a portion of the anterior segment 1020,while in other embodiments the anterior/lateral curve segment 1021 maybe considered a portion of the lateral segment 1022. In otherembodiments, a first portion of the anterior/lateral curve segment 1021may be associated with the anterior segment 1020, while a second portionof the anterior/lateral curve segment 1021 may be associated with thelateral segment 1022. The anterior/lateral curve segment 1021 may havean arc length L₂ in the range of about 0.25 to about 1.5 inches, in therange of about 0.5 to about 1 inches, in the range of about 0.4 to about1.1 inches, or in the range of about 0.43 to about 1.09 inches in someinstances. The anterior/lateral curve segment 1021 may have a radius ofcurvature R₁ of about 0.1 to about 1.25 inches, about 0.2 to about 1inches, about 0.25 to about 0.75 inches, or about 0.24 to about 0.74inches in some instances.

The lateral segment 1022 may include a straight portion located betweenthe anterior/lateral curve segment 1021 and the posterior/lateral curvesegment 1023. Thus, in some embodiments, the lateral segment 1022 mayinclude a straight portion located between a first curved portion and asecond curved portion of the lateral segment 1022. The straight portionof the lateral segment 1022 may have a length L₃ in the range of about0.1 to about 0.5 inches, in the range of about 0.2 to about 0.4 inches,in the range of about 0.15 to about 0.35 inches, or in the range ofabout 0.15 to about 0.35 inches in some instances.

The epicardial clip 1010 may have a posterior/lateral curve segment 1023defining a transition region between the lateral segment 1022 and theposterior segment 1024. In some embodiments, the posterior/lateral curvesegment 1023 may be considered a portion of the lateral segment 1022,while in other embodiments the posterior/lateral curve segment 1023 maybe considered a portion of the posterior segment 1024. In otherembodiments, a first portion of the posterior/lateral curve segment 1023may be associated with the lateral segment 1022, while a second portionof the posterior/lateral curve segment 1023 may be associated with theposterior segment 1024. The posterior/lateral curve segment 1023 mayhave an arc length L₄ in the range of about 0.25 to about 1.5 inches, inthe range of about 0.5 to about 1.0 inches, in the range of about 0.65to about 1.1 inches, or in the range of about 0.64 to about 1.1 inchesin some instances. The posterior/lateral curve segment 1023 may have aradius of curvature R₂ of about 0.2 to about 1.25 inches, about 0.3 toabout 1.0 inches, about 0.4 to about 0.85 inches, or about 0.44 to about0.87 inches in some instances.

The posterior segment 1024, which may be a curved segment of theepicardial clip 1010, may have an arc length L₅ in the range of about 1to about 3 inches, in the range of about 1.25 to about 2.75 inches, inthe range of about 1.5 to about 2.5 inches, or in the range of about1.55 to about 2.5 inches in some instances. The posterior segment 1024may have a radius of curvature R₃ in the range of about 2 to about 5inches, about 2.5 to about 4.5 inches, about 3 to about 4 inches, orabout 2.9 to about 4.1 inches in some instances.

In some embodiments, the anterior segment 1020 may be able to be rotatedrelative to the posterior segment 1024 and/or lateral segment 1022. Forexample, the anterior segment 1020 may be able to be rotated around anaxis running longitudinally through the coupling member 1025 of theanterior segment 1020. In other embodiments, the anterior segment 1020may be oriented at a fixed angle relative to the posterior segment 1024and/or lateral segment 1022.

FIG. 22 is a perspective view of the epicardial clip 1010 with theanterior segment 1020 rotated to a position such that the imaginaryplane in which the anterior segment 1020 lies in is substantiallyperpendicular with the imaginary plane in which the posterior segment1024 and/or the lateral segment 1022 lies in.

FIGS. 23A-23C are side views of the epicardial clip 1010 showing theanterior segment 1020 at three possible rotated positions relative tothe posterior segment 1024 and/or the lateral segment 1022. In someembodiments, the anterior segment 1020 can be rotated to any desiredangle θ relative to the posterior segment 1024 and/or the lateralsegment 1022. FIG. 23A shows the anterior segment 1020 rotated to about90° relative to the posterior segment 1024 and the lateral segment 1022.FIG. 23B shows the anterior segment 1020 rotated to about 60° relativeto the posterior segment 1024 and the lateral segment 1022. FIG. 23Cshows the anterior segment 1020 rotated to about 120° relative to theposterior segment 1024 and the lateral segment 1020. In can beappreciated that in some embodiments the anterior segment 1020 may berotated from about 0° to about 180°, about 30° to about 150°, about 45°to about 135°, about 60° to about 120°, about 70° to about 110°, about80° to about 100°, or between any other desired range of rotation.

FIG. 24 is a top view looking down on the atriums of a heart onto whichthe epicardial clip 1010 has been positioned. As shown in FIG. 24, whenpositioned on the heart, the anterior segment 1020 of the epicardialclip 1010 may be positioned in the transverse sinus TS, posterior to thepulmonary trunk PT and the aorta A, and anterior to the superior venacava SVC. When positioned in the transverse sinus TS, the double-memberof the anterior segment 1020 may be substantially placed vertically inthe transverse sinus TS. For example, the double-member of the anteriorsegment 1020, or another component of the anterior segment 1020 maysubstantially occupy or span the transverse sinus from the inferioraspect of the transverse sinus to the superior aspect of the transversesinus. The position and shape of the anterior segment may be found toprovide enhanced retention and/or stability in the transverse sinus TS.

As shown in FIG. 24, the posterior segment 1024 may be positioned on theepicardial surface of the posterior side of the heart, such as on orinferior to the atrioventricular groove or in the oblique sinus OS.Thus, the distance maintained between the anterior segment 1020 and theposterior segment 1024 may push an anterior wall of the heart toward aposterior wall of the heart, reshaping the geometry of the heart. Forexample, properly positioning the epicardial clip 1010 around a portionof the heart may change the anterior-posterior dimension and/or theseptal-lateral dimension of the mitral valve annulus in order to reshapethe mitral valve annulus to reduce mitral valve regurgitation.

FIGS. 25-29 illustrate alternative configurations of the epicardial clip1010 shown in FIGS. 19 and 20. As shown in FIG. 25, the epicardial clip1010 may include an anchored or non-rotating anterior segment 1020. Insuch an embodiment, the anterior segment 1020 may be formed or chosen tohave a desired angle and/or curvature to complement the anatomicalcontours of a specific patient to ensure forces between the anteriorsegment 1020 and the cardiac structures of the heart are controlled. Forinstance, the anterior segment 1020 shown in FIG. 25 includes a superiorarm portion 1026, an inferior arm portion 1027, and a lateral portion1028 extending between the superior arm portion 1026 and the inferiorarm portion 1027. The inferior arm portion 1027 may be configured torest in the inferior aspect of the transverse sinus. The superior armportion 1026 may be configured to reside in the superior aspect of thetransverse sinus.

In some embodiments, the inferior arm portion 1027 may include an archaving a concave curvature, curving inferiorly, allowing the inferiorarm portion 1027 of the anterior segment 1020 to better conform to thenatural saddle shape of the anterior annulus or floor of the transversesinus, and such that an end portion 1029 of the inferior arm portion1027 may be disposed at and/or in contact with the floor of the septalwall between the right atrium and the left atrium.

As shown in the alternative configuration of FIG. 26, the anteriorsegment 1020 may be a closed loop including a superior arm portion 1026and an inferior arm portion 1027 configured to be located inferior tothe superior portion 1026 when placed in the transverse sinus. Theinferior arm portion 1027 may be located on the floor of the transversesinus, while the superior arm portion 1026 may anchor itself against thereflection of the pericardium that separates the transverse and obliquesinuses at the top of the atrium. Additionally, the lateral segment 1022is shown attached to a median portion of the closed loop of the anteriorsegment 1020 with an attachment point positioned between the superiorarm portion 1026 and the inferior arm portion 1027. In the embodimentshown in FIG. 26, the anterior segment 1020 is free to rotate relativeto the lateral segment 1022 and/or the posterior segment 1024 of theepicardial clip 1010. It has been found that in some instances attachingthe lateral segment 1022 at a median location of the anterior segment1020 while allowing free rotation of the anterior segment 1020 relativeto the other portions of the clip 1010 may help evenly distribute forceson the cardiac structures of the heart between the superior arm portion1026 and the inferior arm portion 1027 of the anterior segment 1020.More evenly distributing forces may reduce bulge of the cardiacstructures by having two smaller bulges as opposed to a single largerbulge.

Similar to that of FIG. 25, the inferior arm portion 1027 shown in FIG.26 may be configured to rest in the inferior aspect of the transversesinus. In some embodiments, the inferior arm portion 1027 may include anarc having a concave curvature, curving inferiorly, allowing theinferior arm portion 1027 of the anterior segment 1020 to better conformto the natural saddle shape of the anterior annulus or floor of thetransverse sinus, and such that an end portion 1029 of the inferior armportion 1027 may be disposed at and/or in contact with the floor of theseptal wall between the right atrium and the left atrium.

The alternative configuration shown in FIG. 27 illustrates the anteriorsegment 1020 having a closed loop connected to the lateral segment 1022of the epicardial clip 1010. The anterior segment 1020 may be rotatablycoupled to the lateral segment 1022 to allow rotation of the anteriorsegment 1020. As shown in FIG. 27, the connection between the anteriorsegment 1020 and the lateral segment 1022 may be proximate the inferiorarm portion 1027 of the anterior segment 1020. In such an embodiment, amajority of the force transmitted to the cardiac structures of the heartis through the inferior arm portion 1027 of the anterior segment 1020.

Additionally, as shown in FIG. 27, the lateral segment 1022 may allowfor repositioning the anterior segment 1020 relative to the posteriorsegment 1024 to adjust the distance between the anterior segment 1020and the posterior segment 1024. For example, lateral segment 1022 mayinclude a rod 1034 over which a coupling portion 1032 of the anteriorsegment 1020 and/or the posterior segment 1024 may be disposed. Thecoupling portion 1032 of the anterior segment 1020 and/or the posteriorsegment 1024 may be slid or moved along the rod 1034 to alter thedistance. The anterior segment 1020 and/or the posterior segment 1024may be secured to the lateral segment 1022, for example with a set screwin the coupling portion 1032, when the desired distance has beenachieved.

Instead of two arm portions separated by a gap or opening, thealternative configuration shown in FIG. 28 illustrates the anteriorsegment 1020 as being a paddle sized to substantially occupy thetransverse sinus from an inferior aspect of the transverse sinus to asuperior aspect of the transverse sinus. The paddle of the anteriorsegment 1020 may have an inferior edge 1051 and a superior edge 1052. Insome embodiments the inferior edge 1051 of the anterior segment 1020 mayhave a concave curvature, curving inferiorly, allowing the inferior edge1051 of the anterior segment 1020 to better conform to the naturalsaddle shape of the anterior annulus or floor of the transverse sinus,and such that an end portion 1059 of the inferior edge 1051 may bedisposed at and/or in contact with the floor of the septal wall betweenthe right atrium and the left atrium, while the curvature of a centralportion of the inferior edge 1051 of the anterior segment 1020 mayprevent the middle portion from adversely pushing into the atrium of theheart.

The configuration of the epicardial clip 1010 shown in FIG. 29 includesan anterior segment 1020 including a rigid or semi rigid superior armportion 1062 and a flexible, or more flexible, inferior arm portion1064. In some embodiments the inferior arm portion 1064, or anotherportion of the anterior segment 1020, may include an elastic band 1066,such as a rubber band. For example, the elastic band 1066 may bestretched between two anchor points 1068, 1069 of the anterior segment1020. The elastic band 1066, used as an inferior arm portion 1064 of theanterior segment 1020 may help conform to the floor of the transversesinus. The two anchor points 1068, 1069 may be configured to supportmost of the force exerted by the epicedial clip 1010, thus the elasticband 1066 may be able to conform to the shape of the floor of thetransverse sinus without pushing excessively on the left atrium oragainst the aorta.

FIG. 30 shows the epicardial clip 1010 with a flap of material 1070extending from the posterior segment 1024. The flap of material 1070 maybe formed of graft material, hernia mesh, or other fabric material, orof a clear flexible material to facilitate visualization of vessels onthe surface of the heart. The flap of material 1070 may be used to helpanchor the clip 1010 to the surface of the heart. For example, the flapof material 1070 may be attached to the surface of the heart with tacks,sutures, or other fasteners.

In some embodiments the flap of material 1070 may be provided with theclip 1010 and attached to the heart after the posterior segment 1024 hasbeen properly positioned. In other embodiments, the flap of material1070 may be attached to the surface of the heart first, then theposterior segment 1024 may be connected to the flap of material when theposterior segment 1024 is being positioned. This arrangement may behelpful in order to maintain consistent positioning of the clip 1010while adjusting, modifying, replacing or otherwise repositioning theclip 1010. In some embodiments, the flap of material 1070 may beconnected to the posterior segment 1024 with sutures, clips, adhesive,tacks, barbs, or other fasteners and fastening means.

FIGS. 31-34 illustrate additional configurations of the epicardial clip1010 including additional mechanical stability features or components.In some instances, the posterior arm 1024 may have a tendency to rotateinto the atrioventricular groove and/or migrate superiorly consequentforces experienced between the clip 1010 and the heart. Thus, in someembodiments, the epicardial clip 1010 may include a mechanical featureextending from the posterior segment 1024 which pushes up on thereflection above the coronary sinus in order to provide a counteringdownward force to help maintain proper positioning of the clip 1010. Forexample, in FIG. 31 the clip 1010 may include an extension 1072 havingtwo arms 1074 extending superiorly from the posterior segment 1024 and across arm 1076 extending between the two arms 1074. In the alternativeembodiment shown in FIG. 32, the cross arm 1076 is connected to theposterior segment 1024 with a single arm 1074. The arm(s) 1074 may havea curvature to complement the anatomical curvature of cardiac structuresof the heart. The cross arm 1076, which may be located superior to theposterior segment 1024 may contact the reflection above the coronarysinus to provide a downward force, as desired.

An additional embodiment, shown in FIG. 33, includes an extension 1080of the anterior segment 1020 which may provide sufficient counterbalanceto maintain the clip 1010 properly positioned on the heart. As shown inFIG. 33, the extension 1080 may include an arm 1082. The arm 1082 may beconnected to a member 1084 extending from the anterior segment 1020. Theconnection between the arm 1082 and the member 1084 may allow the arm1082 to selectively slide and/or rotate relative to the member 1084and/or the anterior segment 1020 of the clip 1010. Once properlypositioned, the arm 1082 may be locked in place (e.g., a set screw) toprevent further sliding and/or rotation of the arm 1082. The arm 1082,pushing against an anatomical region of the heart, may provide thedesired counterbalancing force to maintain the posterior segment 1024 ina desired position.

Downward force on the posterior segment 1024 may also be provided by asling mechanism 1090 that anchors to the apex of the heart, as shown inFIG. 34. The sling mechanism 1090 may include a cap 1092 located at theapex of the heart which is connected to the posterior segment 1024 withone or more, or a plurality of tethers 1094. With the cap 1092positioned inferior to the apex of the heart, the tethers 1094 may helpdraw the posterior segment 1024 downward to maintain the posteriorsegment 1024 in a desired position. In other embodiments, the tether(s)1094 may be anchored to a wall of the heart with one or more anchors,tacks, sutures, or other fasteners.

FIGS. 35-38 illustrate several alternative embodiments of sizing deviceswhich may be used to measure notable dimensions for the epicardial clipto provide proper placement on the heart and/or desired reshaping of themitral valve. Some measurements/dimensions which may be determined usinga sizing device include the cinching distance (i.e., the distancebetween the anterior segment and the posterior segment), the angleand/or curvature of the posterior segment, the length of the posteriorsegment, the angle and/or curvature of the anterior segment, the lengthof the anterior segment, and the height of the anterior segment. In someembodiments, the sizing device may be infinitely adjustable, while inother embodiments the sizing device may discretely adjustable betweenone of a plurality of discrete sizes. The discrete sizes of a discretelyadjustable sizing device may correspond to one of several discrete sizesof an epicardial clip available.

FIG. 35 illustrates one embodiment of a sizing device 1210 which may bediscretely adjustable between one of a plurality of discrete sizes. Thesizing device 1210 includes an anterior segment 1220 and a posteriorsegment 1224, which may resemble the anterior segment and posteriorsegment of an epicardial clip to be positioned on the heart. The lengthof the lateral segment 1222, extending between the anterior segment 1220and the posterior segment 1224, may be adjusted to one of a plurality oflengths. For example, the lateral segment 1222 may include a firstmember 1226 telescoping into a second member 1228. The second member1228 may include an opening 1230 through which a pin 1232, such as aspring loaded pin 1232 may extend into. The first member 1226 mayinclude a plurality of recesses or openings 1234 into which the pin 1232may be inserted. Thus, the first member 1226 may be actuated relative tothe second member 1228 until the opening 1230 of the second member 1228is aligned with a desired recess or opening 1234 of the first member1226, at which point the pin 1232 may extend into the recess or opening1234, locking the lateral segment 1222 at a fixed length. The distancebetween the anterior segment 1220 and the posterior segment 1224 may bechanged stepwise until a desired distance is determined.

FIG. 36 illustrates another embodiment of a sizing device 1310 which maybe discretely adjustable between one of a plurality of discrete sizes.The sizing device 1310 includes an anterior segment 1320 and a posteriorsegment 1324, which may resemble the anterior segment and posteriorsegment of an epicardial clip to be positioned on the heart. The lengthof the lateral segment 1322, extending between the anterior segment 1320and the posterior segment 1324, may be adjusted to one of a plurality oflengths. For example, the lateral segment 1322 may include a firstmember 1326 telescoping into a second member 1328. The first member 1326may include a plurality of dogs or teeth 1334 (such as a ratchetconfiguration) extending from one side of the first member 1326. An arm1332 extending from the second member 1328 may engage one of the teeth1334 to prevent further elongation of the posterior segment 1324 fromthe anterior segment 1320. The orientation of the teeth 1334 may allowthe lateral segment 1322 to be initially elongated, thus allowing theposterior segment 1324 to be drawn toward the anterior segment 1320 in astepwise fashion. As the posterior segment 1324 is moved toward theanterior segment 1320, the arm 1332 may be actuated out of engagementwith one of the teeth 1334 and into engagement with an adjacent tooth1334 until a desired distance between the posterior segment 1324 and theanterior segment 1320 is attained. Thus, the first member 1326 may beactuated relative to the second member 1328 until the arm 1332 ispositioned at a desired tooth 1334 along the first member 1326. Thedistance between the anterior segment 1220 and the posterior segment1224 may be changed stepwise until a desired distance is determined.

FIG. 37 illustrates yet another embodiment of a sizing device 1410 whichmay be adjustable. The sizing device 1410 includes an anterior segment1420 and a posterior segment 1424, which may resemble the anteriorsegment and posterior segment of an epicardial clip to be positioned onthe heart. The length of the lateral segment 1422, extending between theanterior segment 1420 and the posterior segment 1424, may be adjusted toone of a plurality of lengths. For example, the lateral segment 1422 mayinclude a first member 1426 telescoping into a second member 1428. Thefirst member 1426 may include a plurality of dogs or teeth 1434 (such asa ratchet configuration) extending from one side of the first member1426. The orientation of the teeth 1434 may allow the lateral segment1422 to be initially elongated, thus allowing the posterior segment 1424to be drawn toward the anterior segment 1420 until a desired distance isattained. The first member 1426 may slideably engage the second member1428 such as in a channel of the second member 1428. A surface of thesecond member 1428 may include a tab or projection (not shown) whichengages the teeth 1434 of the first member 1426 as the first member 1426is moved relative to the second member 1428. As the posterior segment1424 is moved toward the anterior segment 1420, the tab or projection ofthe second member 1428 engages in the groove between two adjacent teeth1434 to resist movement of the first member 1426 in the oppositedirection. The first member 1426 may be actuated relative to the secondmember 1428 until the posterior segment 1424 is positioned at a desireddistance from the anterior segment 1420, at which point the tab orprojection of the second member 1428 may be engage one of the teeth 1434to resist movement between the first member 1426 and the second member1428 in the opposite direction, which may be described as a ratcheteffect. The ratchet effect of the teeth 1434 may allow the distancebetween the anterior segment 1220 and the posterior segment 1224 may bechanged until a desired distance is determined.

Another sizing device 1510 is illustrated in FIG. 38. The sizing device1510 includes an anterior segment 1520 and a posterior segment 1524,which may resemble the anterior segment and posterior segment of anepicardial clip to be positioned on the heart. The length of the lateralsegment 1522, extending between the anterior segment 1520 and theposterior segment 1524, may be adjusted to one of a plurality oflengths. For example, the lateral segment 1522 may include a threadedrod 1532 and a non-threaded rod 1534 extending between the anteriorsegment 1520 and the posterior segment 1524. The threaded rod 1532 andthe non-threaded rod 1534 may extend from the anterior segment to a gearbox 1540. A knob 1542 may extend from the gear box 1540. The knob 1542may be secured to a shaft which is in turn secured to a gear 1544 in thegear box 1540. The gear 1544 may mesh with a gear 1546 secured to thethreaded rod 1532. Thus, rotation of the knob 1542 may rotate thethreaded rod 1532.

Rotation of the threaded rod 1532 may adjust the distance between theanterior segment 1520 and the posterior segment 1524. For example, inembodiments in which the anterior segment 1520 includes a threaded boreengaging the threads of the threaded rod 1532, rotation of the threadedrod 1532 may advance the anterior segment 1520 along the threaded rod1532. In such an embodiment, the posterior segment 1524 may remain in astationary location along the length of the threaded rod 1532. Theinclusion of the non-threaded rod 1534 may prevent rotation of theanterior segment 1520 as the threaded rod 1532 is rotated, while stillallowing translational movement of the anterior segment 1520 along thethreaded rod 1532 and the non-threaded rod 1534.

In embodiments in which the posterior segment 1524 includes a threadedbore engaging the threads of the threaded rod 1532, rotation of thethreaded rod 1532 may advance the posterior segment 1524 along thethreaded rod 1532. In such an embodiment, the anterior segment 1524 mayremain in a stationary location along the length of the threaded rod1534. The inclusion of the non-threaded rod 1534 may prevent rotation ofthe posterior segment 1524 as the threaded rod 1532 is rotated, whilestill allowing translational movement of the posterior segment 1524along the threaded rod 1532 and the non-threaded rod 1534.

The knob 1542 may be rotated until a desired distance between theanterior segment 1520 and the posterior segment 1524 is attained,allowing for an infinitely adjustable distance between the anteriorsegment 1520 and the posterior segment 1524.

FIG. 39A illustrates a C-shaped or U-shaped epicardial clip 1110. Theepicardial clip 1110 includes a first leg 1112, a second leg 1114, and aback portion 1116 connecting the first leg 1112 and the second leg 1114.In some embodiments, the first leg 1112 may be substantially parallelwith the second leg 1114. The first leg 1112 may be approximatelyperpendicular to the back portion 1116, and the second leg 1114 may beapproximately perpendicular to the back portion 1116. A first tubularcuff 1122, having a lumen, may extend along the first leg 1112, and asecond tubular cuff 1124, having a lumen, may extend along the secondleg 1114. A first malleable element 1132 may be located on the first leg1112, for example proximate the end of the first tubular cuff 1122. Asecond malleable element 1134 may be located on the second leg 1114, forexample proximate the end of the second tubular cuff 1124.

The clip 1110 may be formed of a spring material such that the clip 1110may be collapsed into a low profile, yet allows the clip 1110 to recoverits original shape when released after being distorted by an appliedforce.

FIG. 39B illustrates an alternative arrangement of the clip 1110including torsion spring loops 1140 at the corners between the first leg1112 and the intermediate portion 1116, and the second leg 1114 and theintermediate portion 1116. The torsion spring loops 1140 may facilitatethe ability of the clip 1110 to be collapsed into a low profileconfiguration, yet the torsion spring loops 1140 may allow the clip 1110to recover its original shape when released after being distorted by anapplied force.

The clip 1110 may be collapsed and loaded into the lumen 1152 of adelivery tube 1150 as shown in FIG. 40. For example, the clip 1110 maybe collapsed such that the second leg 1114 and the back portion 1116 arefolded against the first leg 1112, thus the clip 1110 lies substantiallyflat. A medical device, such as a grasper 1160 may be introduced intothe delivery tube 1150 to deploy and/or maneuver the clip 1110 withinthe thoracic cavity of a patient. In other embodiments a rigid rod orother actuatable member may be used to deploy and/or maneuver the clip1110 from the delivery tube 1150.

The clip 1110 may be positioned on the heart of a patient during aclosed-chest, endoscopic procedure in order to adjust theanterior-posterior dimension of the annulus of the mitral valve toenhance coaptation of the leaflets of the mitral valve. This endoscopicapproach positions the first leg 1112 of the clip 1110 in the transversesinus and the second leg 1114 of the clip 1110 on the posterior side ofthe heart, such as on or inferior to the atrioventricular groove or inthe oblique sinus of the heart.

An exemplary medical procedure for positioning the clip 1110 on theheart includes forming a first thoracoscopic port and a secondthoracoscopic port in the right chest of the patient. For example, thefirst thoracoscopic port may be a 12 millimeter port in the third,fourth or fifth intercostal space. The second throracosopic port may bea 5 millimeter port in the third, fourth or fifth intercostal space. Theelongate shaft of an endoscope may be inserted through the firstthoracoscopic port into the thoracic cavity. A medical grasping devicemay be advanced through the working channel of the endoscope into thethoracic cavity of the patient, while endoscopic shears or other cuttingdevice is inserted through the second thoracoscopic port into thethoracic cavity. It is noted that in some embodiments, the cuttingdevice may be inserted through the working channel of the endoscope andthe grasping device may be advanced through the second port. In otherembodiments in which the endoscope has two working channels, each of thedevices may be advanced through one of the working channels of theendoscope. The grasping device may be used to grasp a portion of thepericardium, while the cutting device may be used to incise the rightpericardium to gain access to pericardial cavities. For example, theright pericardium may be incised about 1 to 2 centimeters anterior tothe right phrenic nerve. The endoscope, grasping device and cuttingdevice may then be withdrawn from the ports.

A visualization cannula 1170, such as a blunt tipped visualizationcannula, may then be introduced through the first port. As shown in FIG.41, the visualization cannula 1170 may be inserted through the incisionmade in the pericardium and positioned into the transverse pericardialsinus via a path anterior to the superior vena cava and posterior to theascending aorta. A snare catheter 1180 may be advanced through thevisualization cannula 1170 into the transverse sinus. The snare catheter1180 may be tracked around the left lateral side of the heart from thetransverse sinus to the posterior side of the heart, such as on orinferior to the atrioventricular groove or into the oblique sinus. Thesnare catheter 1180 may be positioned inferior to the left pulmonaryveins. In some embodiments the snare catheter 1180 may be positionedinferior to the left atrial appendage, while in other embodiments thesnare catheter 1180 may be positioned superior to the left atrialappendage.

As shown in FIG. 42, with the distal end of the snare catheter 1180 onthe posterior side of the heart, the visualization cannula 1170 may berepositioned on the posterior side of the heart. The distal end of thesnare catheter 1180 may then be retrieved and withdrawn into thevisualization cannula 1170 and out the thoracoscopic port exterior ofthe chest of the patient. With both the proximal end and the distal endof the snare catheter 1180 located exterior of the patient, thevisualization cannula 1170 may be withdrawn from the thoracoscopic port,leaving the snare catheter 1180 in place.

As shown in FIG. 43, the first and second cuffs 1122/1124 of the clip1110 may then be loaded onto the snare catheter 1180. The proximal endof the snare catheter 1180 may be loaded through the lumen of the firstcuff 1122 and the distal end of the snare catheter 1180 may be loadedthrough the lumen of the second cuff 1124. The clip 1110 may then becollapsed and loaded into the delivery tube 1150.

The delivery tube 1150 may be advanced into the thoracic cavity througha thoracoscopic port to a location proximate the heart. When thedelivery tube 1150 and clip 1110 are positioned in proximity to theheart, the clip 1110 may be deployed from the delivery tube 1150. Forexample, the grasper 1160, or a rigid rod, may be used to expel the clip1110 out of the delivery tube 1150. Once deployed from the delivery tube1150, the clip may revert back to its expanded configuration of aC-shape or U-shape.

The grasper 1160 may then be used to advance the clip 1110 along thesnare catheter 1180 until the first leg 1112 is positioned in thetransverse sinus and the second leg 1114 is positioned on the posteriorside of the heart, such as on or inferior to the atrioventricular grooveor in the oblique sinus. The placement of the snare catheter 1180 mayguide the clip 1110 into proper placement. Echocardiographic images maybe taken to determine the optimal or desired position of the clip 1110.The clip 1110 may be slid over the snare catheter 1180, cinching down onthe heart, until a desired functionality of the mitral valve isattained. Once properly positioned, the malleable elements 1132/1134 maybe crimped to the snare catheter 1180 to secure the clip 1110 to thesnare catheter 1180 and prevent further relative movement between thetwo. Excess lengths of the snare catheter 1180 extending out of thepatient's body from the first leg 1112 and the second leg 1114 may thenbe trimmed and removed from the patient.

A completed clip implantation is shown in FIG. 44. The position of theclip 1110 and the remaining portion of the snare catheter 1180 extendingaround the heart provides an inward force on the walls of the heart,altering the anterior-posterior dimension across the annulus of themitral valve. Reshaping the annulus of the mitral valve may improvecoaptation of the leaflets of the mitral valve, and thus improve theefficiency of the heart.

The devices and methods described herein are discussed while referringto a human heart, but may be equally adaptable to other animal hearts,as desired. Furthermore, the devices and methods described herein arediscussed while referring to the mitral valve of a heart, but one ofskill in the art may also find some features useful with treating thetricuspid valve or other heart valve.

Those skilled in the art will recognize that the present invention maybe manifested in a variety of forms other than the specific embodimentsdescribed and contemplated herein. Accordingly, departure in form anddetail may be made without departing from the scope and spirit of thepresent invention as described in the appended claims.

1. An epicardial clip for reshaping the annulus of the mitral valve of aheart, the mitral valve lying in a plane between the left atrium and theleft ventricle of the heart, the anatomy of the heart includes an aorta,a pulmonary trunk, a superior vena cava, a transverse sinus, an obliquesinus, and an atrioventricular groove, the clip comprising: a curvedmember having a first end and a second end, the member forming: a) ananterior segment configured to be positioned in the transverse sinus ofthe heart; b) a posterior segment configured to be positioned on orinferior to the atrioventricular groove of the heart; and c) a lateralsegment extending between the anterior segment and the posteriorsegment, the lateral segment including a curve such that the first endof the member is positioned on or above the plane of the mitral valveand the second end of the member is positioned on or below the plane ofthe mitral valve; wherein the transverse sinus is a pericardial cavityof the heart located posterior to the aorta and pulmonary trunk andanterior to the superior vena cava; and wherein the atrioventriculargroove is a natural junction between the left atrium and the leftventricle of the heart on a posterior side of the heart.
 2. Theepicardial clip of claim 1, wherein the curve is a helical curve.
 3. Theepicardial clip of claim 2, wherein when the curved member is viewedlaterally, an acute angle is defined between the anterior segment andthe posterior segment.
 4. The epicardial clip of claim 1, wherein theanterior segment is substantially straight.
 5. The epicardial clip ofclaim 1, wherein the posterior segment is arced.
 6. The epicardial clipof claim 1, further comprising a compliant material encasing at least aportion of the member.
 7. The epicardial clip of claim 6, wherein thecompliant material is an over-mold. 8 The epicardial clip of claim 6,wherein the compliant material is silicone.
 9. The epicardial clip ofclaim 6, wherein the compliant material includes a flat section on theposterior segment.
 10. The epicardial clip of claim 6, wherein thecompliant material includes a rounded section on the anterior segment.11. The epicardial clip of claim 6, wherein a fabric sheath covers thecompliant material.
 12. The epicardial clip of claim 11, wherein thefabric sheath promotes tissue growth thereon.
 13. The epicardial clip ofclaim 11, wherein the fabric sheath promotes tissue growth therein. 14.An epicardial clip for placement on the epicardial surface of a heart inorder to reshape the annulus of the mitral valve of the heart, themitral valve lying in a plane between the left atrium and the leftventricle of the heart, the anatomy of the heart includes an aorta, apulmonary trunk, a superior vena cava, a transverse sinus, and anatrioventricular groove, the epicardial clip comprising: a curved memberhaving an anterior segment, a posterior segment and a lateral segmentextending between the anterior segment and the posterior segment;wherein the anterior segment includes a component that occupies thetransverse sinus from an inferior aspect of the transverse sinus to asuperior aspect of the transverse sinus.
 15. The epicardial clip ofclaim 14, wherein the component of the anterior segment includes adouble-arm member including a first arm and a second arm forming aU-shape.
 16. The epicardial clip of claim 14, wherein the component ofthe anterior segment includes a superior arm portion connected to aninferior arm portion.
 17. The epicardial clip of claim 16, wherein theinferior arm portion includes an elastic band stretched between a firstanchor point and a second anchor point.
 18. The epicardial clip of claim16, wherein the inferior arm portion is positioned at the inferioraspect of the transverse sinus.
 19. The epicardial clip of claim 18,wherein the superior arm portion is positioned at the superior aspect ofthe transverse sinus.
 20. The epicardial clip of claim 14, wherein thecurved member includes a coupler for coupling the anterior segment tothe lateral segment.
 21. The epicardial clip of claim 20, wherein thecoupler has an imaginary longitudinal axis, and wherein the anteriorsegment is rotatable about the imaginary longitudinal axis of thecoupler.
 22. The epicardial clip of claim 21, wherein the anteriorsegment is rotatable through an angle of at least 30 degrees.
 23. Theepicardial clip of claim 21, wherein the anterior segment is rotatablethrough an angle of at least 60 degrees.
 24. The epicardial clip ofclaim 14, wherein the anterior segment is positioned in the transversesinus and the posterior segment is positioned at or below theatrioventricular groove.
 25. The epicardial clip of claim 14, whereinthe component of the anterior segment lies in an imaginary plane and theposterior segment lies in another imaginary plane, wherein the componentof the anterior segment does not lie in the imaginary plane of theposterior segment.
 26. The epicardial clip of claim 14, wherein theposterior segment includes an over-mold covering.
 27. An epicardial clipfor reshaping the annulus of the mitral valve of a heart, the heartincluding a left atrium, a left ventricle, a transverse sinus, and anatrioventricular groove, the mitral valve lying in a plane between theleft atrium and the left ventricle of the heart, the clip comprising: acurved member having a first end and a second end, the member forming:i) an anterior segment positioned on or superior to the plane of themitral valve; ii) a posterior segment positioned on or inferior to theplane of the mitral valve; and iii) a lateral segment extending betweenthe anterior segment and the posterior segment, the lateral segmentincluding a curve extending around a lateral portion of the heart. 28.The epicardial clip of claim 27, wherein the curve is a helical curve.29. The epicardial clip of claim 27, wherein the plane of the mitralvalve intersects at least one of the lateral segment and the posteriorsegment.
 30. The epicardial clip of claim 27, wherein the anteriorsegment includes a curved portion having a curvature opposite that ofthe curvature of the lateral segment.
 31. The epicardial clip of claim27, wherein the anterior segment includes a curved portion having acurvature generally perpendicular to a curvature of the curve of thelateral segment.
 32. The epicardial clip of claim 31, wherein the curvedportion of the anterior segment follows a curvature of an aortaextending from the heart.
 33. The epicardial clip of claim 27, whereinthe anterior segment includes a curved portion having a curvaturegenerally perpendicular to the plane of the mitral valve.
 34. Theepicardial clip of claim 33, wherein the curved portion of the anteriorsegment follows a curvature of a floor of the transverse sinus.
 35. Theepicardial clip of claim 27, wherein the anterior segment is positionedin the transverse sinus.
 36. The epicardial clip of claim 27, whereinthe posterior segment is positioned on or inferior to theatrioventricular groove.
 37. The epicardial clip of claim 27, wherein atleast a portion of the member is covered with a biocompatible covering.38. The epicardial clip of claim 37, wherein the biocompatible coveringis a silicone material.
 39. The epicardial clip of claim 27, wherein theclip further includes one or more pads extending from the member tocontact an exterior surface of the heart.
 40. The epicardial clip ofclaim 27, wherein the anterior segment is proximate the first end of themember, and wherein the clip further includes a bulbous member disposedat the first end of the member.
 41. The epicardial clip of claim 27,further comprising a compliant material encasing at least a portion ofthe member.
 42. The epicardial clip of claim 41, wherein the posteriorsegment and the lateral segment are encased with the compliant material,and wherein the anterior segment is not encased with the compliantmaterial.
 43. The epicardial clip of claim 27, further comprising afabric material covering at least a portion of the member.
 44. Theepicardial clip of claim 27, further comprising a bioabsorbable coveringmaterial covering at least a portion of the member.
 45. An epicardialclip for reshaping the annulus of the mitral valve of a heart, whereinthe epicardial clip may be defined in an imaginary coordinate systemhaving an origin, an x-axis extending from the origin, a y-axisextending from the origin and perpendicular to the x-axis, and a z-axisextending from the origin and perpendicular to both the x-axis and they-axis, the clip comprising: a curved member having a first end and asecond end, the first end of the member positioned at the origin; themember forming an anterior segment, a posterior segment, and a lateralsegment extending between the anterior segment and the posteriorsegment; the anterior segment beginning at the origin and extending in apositive x-direction along the x-axis; the lateral segment extendingfrom the anterior segment including a straight portion extending in apositive y-direction and a curve portion extending to the posteriorsegment; the posterior segment extending from the lateral segment in anegative x-direction.
 46. The epicardial clip of claim 45, wherein thelateral segment generates a coordinate change in a z-direction.
 47. Theepicardial clip of claim 45, wherein the posterior segment generates acoordinate change in an x-direction, a coordinate change in ay-direction, and a coordinate change in a z-direction.
 48. An epicardialclip for reshaping the annulus of the mitral valve of a heart, whereinthe epicardial clip may be defined in an imaginary coordinate systemhaving an origin, an x-axis extending from the origin, a y-axisextending from the origin and perpendicular to the x-axis, and a z-axisextending from the origin and perpendicular to both the x-axis and they-axis, the clip comprising: a curved member having a first end and asecond end, the first end of the member positioned at the origin; themember forming an anterior segment, a posterior segment, and a lateralsegment extending between the anterior segment and the posteriorsegment; the anterior segment beginning at the origin and extending inthe x-direction along the x-axis; the lateral segment including ahelical curve extending from the anterior segment and generating acoordinate change in the z-direction between the anterior segment andthe posterior segment; and the posterior segment extending from thelateral segment and generating a coordinate change in the x-direction, acoordinate change in the y-direction and a coordinate change in thez-direction.
 49. The epicardial clip of claim 48, wherein the coordinatesystem further includes an x-y plane parallel to both the x-axis and they-axis, an x-z plane parallel to both the x-axis and the z-axis, and ay-z plane parallel to both the y-axis and the z-axis, wherein theposterior segment does not lay in the x-y plane, the x-z plane, or they-z plane of the coordinate system.
 50. The epicardial clip of claim 48,wherein the posterior segment includes an arc.
 51. The epicardial clipof claim 48, wherein the anterior segment includes a straight portion.52. The epicardial clip of claim 48, wherein the lateral segment has aradius of curvature in the range of about 5 to 70 millimeters.
 53. Theepicardial clip of claim 48, wherein the lateral segment has a radius ofcurvature in the range of about 30 to 46 millimeters.
 54. The epicardialclip of claim 48, wherein the lateral segment includes a first curvedportion, a second curved portion, and a straight portion intermediatethe first curved portion and the second curved portion.
 55. Theepicardial clip of claim 48, wherein the distance across the clipbetween the anterior segment and the posterior segment is closestbetween the first end of the curved member and the second end of thecurved member.
 56. A clip positioned around an epicardial surface of aheart interior of the pericardium surrounding the heart, the anatomy ofthe heart includes an aorta, a pulmonary trunk, a superior vena cava, atransverse sinus, and an atrioventricular groove, the clip comprising: acurved member having a first end and a second end, the member forming:a) an anterior segment extending from the first end; b) a posteriorsegment extending from the second end; and c) a lateral segmentextending between the anterior segment and the posterior segment, thelateral segment including a curve; wherein when the curved member isviewed from above, the member has a U-shape.
 57. The clip of claim 56,wherein when the curved member is viewed laterally, an acute angle isdefined between the anterior segment and the posterior segment.
 58. Theclip of claim 56, wherein the curve is a helical curve.
 59. The clip ofclaim 56, wherein the anterior segment is located in an imaginary planeand the posterior segment is located in an imaginary plane, wherein theimaginary plane of the posterior segment is at an acute angle to theimaginary plane of the anterior segment.
 60. The clip of claim 56,wherein the anterior segment is configured to be positioned in thetransverse sinus of the heart posterior to the aorta and pulmonary trunkand anterior to the superior vena cava.
 61. The clip of claim 56,wherein the posterior segment is configured to be positioned on orinferior to the atrioventricular groove of the heart.
 62. A method ofepicardial treatment of mitral regurgitation associated with the mitralvalve of a heart, the anatomy of the heart including an aorta, apulmonary trunk, a superior vena cava, a transverse sinus, a left atrialappendage, and an oblique sinus, the method comprising: providing a cliphaving an anterior segment, a posterior segment, and a lateral segmentextending between the anterior segment and the posterior segment;positioning the anterior segment in the transverse sinus of the heart;and positioning the posterior segment on or inferior to theatrioventricular groove of the heart; wherein the clip reshapes theannulus of the mitral valve.
 63. The method of claim 62, wherein theposterior segment applies pressure on the posterior wall of the leftventricle, improving coaptation of the mitral valve.
 64. The method ofclaim 62, wherein the lateral segment extends around a lateral side ofthe heart below the left atrial appendage of the heart.
 65. The methodof claim 62, wherein the lateral segment extends around a lateral sideof the heart above the left atrial appendage of the heart.
 66. Themethod of claim 62, wherein the mitral valve lies in a plane, andwherein the anterior segment extends above the plane of the mitralvalve.
 67. The method of claim 62, wherein the mitral valve lies in aplane, and wherein the posterior segment extends below the plane of themitral valve.
 68. The method of claim 62, further comprising a padextending from the clip, wherein the pad applies pressure on theposterior wall of the left ventricle, improving coaptation of the mitralvalve.
 69. A method of epicardial treatment of mitral regurgitationassociated with the mitral valve of a heart of a patient, the anatomy ofthe heart including a right atrium, a right ventricle, a left atrium, aleft ventricle, an aorta, a pulmonary trunk, a superior vena cava, atransverse sinus, an oblique sinus, an atrioventricular groove, rightpulmonary veins, left pulmonary veins, pericardium, and a left atrialappendage, the method comprising: providing a thoracoscopic port in theright chest of the patient; advancing an endoscopic device through thethoracoscopic port; incising the right pericardium to gain access to apericardial cavity; advancing a visualization cannula into thetransverse pericardial sinus via a path anterior to the superior venacava and posterior to the ascending aorta; tracking a distal end of asnare catheter from the transverse sinus into the oblique sinus while aproximal end of the snare catheter remains exterior of the chest of thepatient through the thoracoscopic port; repositioning the visualizationcannula into the oblique sinus; retrieving the distal end of the snarecatheter; withdrawing the distal end of the snare catheter out of thethoracoscopic port exterior of the chest of the patient; providing aclip having a first leg, a second leg and a central portion between thefirst leg and the second leg; loading the clip onto the proximal end andthe distal end of the snare catheter exterior of the thoracoscopic port;advancing the clip, disposed in a delivery tube, through thethoracoscopic port; deploying the clip from the delivery tube, therebyexpanding the clip; advancing a portion of the clip into the transversesinus and a portion of the clip into the oblique sinus or at or inferiorto the atrioventricular groove; securing the snare catheter to the firstleg of the clip and the second leg of the clip; and excising excesslengths of the snare catheter.
 70. The method of claim 69, wherein thethoracoscopic port is located in the third intercostal space.
 71. Themethod of claim 69, wherein the thoracoscopic port is located in thefifth intercostal space.
 72. The method of claim 69, wherein the rightpericardium is incised 1-2 cm anterior to the right phrenic nerve. 73.The method of claim 69, wherein the snare catheter is crimped to thefirst leg of the clip and the snare catheter is crimped to the secondleg of the clip.